Product code GAN— General, Plastic Surgery
DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
- Classification name
- Suture, Absorbable, Synthetic
- Device class
- Class 2
- Regulation
- 21 CFR 878.4830
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code GAN
FDA has cleared devices under product code GAN between 1990 and 2000, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2000
- 1996
- 1995
- 1994
- 1990
Top applicants under product code GAN
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 →
Recent clearances under product code GAN
- K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
- K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
- K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
- K951231 — ORTHOPEDIC PACKS
- K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
- K895579 — POLYSORB SYNTHETIC ABSORBABLE SUTURE
- K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
Data sourced from openFDA. This site is unofficial and independent of the FDA.