Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S
Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S: 510(k) cleared for Ambu A/S. Its amount of 140 is above the median of 138 (52nd percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 140 · 52th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related DK FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261400 |
| Device | Ambu® aScope Gastro; Ambu® aScope Gastro Large |
| Applicant | Ambu A/S |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FDS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-29 |
| Decision date | 2026-09-16 |
| Review time (days) | 140 |
| Third-party review | No |
| Applicant location | Ballerup, DK |
| amount percentile | 52th of 414 (median 138, 1.0x median) |
| Peer records CSV (4 DK records) | 🔒 Click to unlock → |
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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: 2026-09-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (DK first): Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aScope 5 Broncho 4.2 · Elos Accurate Hybrid Base (K261327) · BoneXpert (K262390) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
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: Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S and 4 DK peers
- DK FDAPulse records like this one: 4
- Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S's amount: 52nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every DK peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 140-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S?
Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400) by Ambu A/S was cleared on 2026-09-16 after 140 days of review.
How does Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400): 510(k) cleared for Ambu A/S compare to other FDAPulse records?
Its amount of 140 sits in the upper half (52th percentile) of 414 records; the median is 138. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ambu® aScope Gastro; Ambu® aScope Gastro Large (K261400) | DK | 2026-09-16 |
| 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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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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