Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin
Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin (Indiana): gastroenterology & urology. Its amount of 156 is above the median of 138 (58th percentile). Dated 12 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-03, 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: 156 · 58th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 12 related IN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261670 |
| Device | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads |
| Applicant | Poly Medicure Limited |
| Specialty / panel | Gastroenterology, Urology |
| Product code | LJH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-20 |
| Decision date | 2026-10-23 |
| Review time (days) | 156 |
| Third-party review | No |
| Applicant location | Jaipur, IN |
| amount percentile | 58th of 414 (median 138, 1.1x median) |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin
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Unlock Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin + all 13 IN records (CSV)
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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: 2026-10-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin's amount: 58th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Indiana peer: $2,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 156-day review, longer than typical.
- Posted 12 days ago.
What is the FDAPulse record for Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin in Indiana?
Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Single Spike, Tubing 80, with Luer Lock - Sterile (30034); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 80, with Luer Lock- Sterile (30035); Polymed TUR Irrigation Set, Y- Type, 4 Leads (K261670) by Poly Medicure Limited was cleared on 2026-10-23 after 156 days of review.
How does Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin compare to other Indiana FDAPulse records?
Its amount of 156 sits in the upper half (58th percentile) of 414 records; the median is 138. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin | IN | 2026-10-23 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
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How to monitor Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin and peer gastroenterology & urology records
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