MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)— 510(k) K960653
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K960653 for MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED), Substantially Equivalent on 1996-03-28. Applicant: ETHICON, Inc.. Device class: 2.
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code GAN
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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Adverse events under product code GAN
product code GAN- Injury
- 599
- Malfunction
- 1,658
- Total
- 2,257
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K960653
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.