Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.
Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. (Pennsylvania): 510(k) cleared for TELA Bio, Inc. Its amount of 228 is above the median of 138 (72nd percentile). Dated 38 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 228 · 72th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260474 |
| Device | Liora Monofilament Scaffold |
| Applicant | TELA Bio, Inc. |
| Specialty / panel | General, Plastic Surgery |
| Product code | FTL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-12 |
| Decision date | 2026-09-28 |
| Review time (days) | 228 |
| Third-party review | No |
| Applicant location | Malvern, PA, US |
| amount percentile | 72th of 414 (median 138, 1.7x median) |
| Peer records CSV (19 PA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio + all 19 PA records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (PA first): 25G Huber Needle (K254095) · Pro-Line XL Power Injectable Central Venous Catheter and Pro · VacHeal Negative Pressure Wound Therapy System (K254160) · Ventricular Catheters, Thomale Catheter (K260044) · Gravity Blood Sets with 200µm Filter (K260261) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.'s amount: 72nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 228-day review, longer than typical.
- Posted 38 days ago.
What is the FDAPulse record for Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. in Pennsylvania?
Liora Monofilament Scaffold (K260474) by TELA Bio, Inc. was cleared on 2026-09-28 after 228 days of review.
How does Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. compare to other Pennsylvania FDAPulse records?
Its amount of 228 sits in the upper half (72th percentile) of 414 records; the median is 138. It is 38 days old, still within a typical 45-day follow-up window.
Liora Monofilament Scaffold (K260474) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Liora Monofilament Scaffold (K260474) | PA | 2026-09-28 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
Related records
- TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
- easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.
- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
- Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC
- Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.
- SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.
- VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC
- MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation
- HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC
- Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated
- Versius Surgical System (Versius Plus) (K261252): 510(k) cleared for Cmr Surgical Limited
- Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) (K261572): 510(k) cleared for Keyue (Hangzhou) Medical Information Technology Co., Ltd.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
More Pennsylvania public-record feeds
New Grants by Vendor Procurement Need in Pennsylvania Credit Union Quarterly Changes, Mergers & New Charters (NCUA Call Reports) in Pennsylvania FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in Pennsylvania New NIH Research Awards by Organization in Pennsylvania Pennsylvania Air Quality Continuous Emission Monitoring System 1986 Pulse in Pennsylvania SEC 8-K Corporate Trigger Events in Pennsylvania Excluded Health Care Business Search (OIG LEIE) in Pennsylvania New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Pennsylvania
How to monitor Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. and peer general & plastic surgery records
Get new FDAPulse records like Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.