Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited
Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited: 510(k) cleared for Cyden Limited. Its amount of 105 is below the median of 138 (38th percentile). Dated 40 days ago, it serves as a historical benchmark. Score 41/100. 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: 105 · 38th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 7 related GB FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261977 |
| Device | Braun Aura 9 (6042) |
| Applicant | Cyden Limited |
| Specialty / panel | General, Plastic Surgery |
| Product code | OHT |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-06-12 |
| Decision date | 2026-09-25 |
| Review time (days) | 105 |
| Third-party review | No |
| Applicant location | Swansea, GB |
| amount percentile | 38th of 414 (median 138, 0.8x median) |
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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: 2026-09-25
- 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: Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited and 8 GB peers
- GB FDAPulse records like this one: 8
- Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited's amount: 38th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every GB peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 105-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 40 days ago.
What is the FDAPulse record for Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited?
Braun Aura 9 (6042) (K261977) by Cyden Limited was cleared on 2026-09-25 after 105 days of review.
How does Braun Aura 9 (6042) (K261977): 510(k) cleared for Cyden Limited compare to other FDAPulse records?
Its amount of 105 is below the median (38th percentile); smaller records often move faster and face less competition. It is 40 days old, still within a typical 45-day follow-up window.
Braun Aura 9 (6042) (K261977) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Braun Aura 9 (6042) (K261977) | GB | 2026-09-25 |
| 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
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- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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