Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH
Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH (Delaware): 510(k) cleared for Tontarra Medizintechnik GmbH. Its amount of 216 is above the median of 138 (70th percentile). Dated 50 days ago, it serves as a historical benchmark. Score 42/100. 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: 216 · 70th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260446 |
| Device | Tontarra Punches and Rongeurs |
| Applicant | Tontarra Medizintechnik GmbH |
| Specialty / panel | Neurology |
| Product code | HAE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-11 |
| Decision date | 2026-09-15 |
| Review time (days) | 216 |
| Third-party review | No |
| Applicant location | Wurmlingen, DE |
| amount percentile | 70th of 414 (median 138, 1.6x median) |
| Peer records CSV (25 DE 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: 2026-09-15
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH's amount: 70th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 216-day review, longer than typical.
What is the FDAPulse record for Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH in Delaware?
Tontarra Punches and Rongeurs (K260446) by Tontarra Medizintechnik GmbH was cleared on 2026-09-15 after 216 days of review.
How does Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH compare to other Delaware FDAPulse records?
Its amount of 216 sits in the upper half (70th percentile) of 414 records; the median is 138. It is 50 days old; check the official source for later updates before acting.
Tontarra Punches and Rongeurs (K260446) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Tontarra Punches and Rongeurs (K260446) | DE | 2026-09-15 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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