Suture, Absorbable, Synthetic
The Suture, Absorbable, Synthetic (product code GAN) is a synthetic absorbable suture designed to hold tissue together during healing and then be gradually broken down and resorbed by the body, avoiding the need for later removal. It is classified as FDA Class 2, posing moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 878.4830 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is implanted within tissue during surgical wound closure.
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Basic Information
- Product Code
- GAN
- Device Class
- FDA class 2
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | Dec 15, 2000 | Substantially Equivalent | Surgical Specialties Corp |
| K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | Dec 18, 1996 | Substantially Equivalent | ETHICON, Inc. |
| K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | Mar 28, 1996 | Substantially Equivalent | ETHICON, Inc. |
| K951231 | ORTHOPEDIC PACKS | Dec 01, 1995 | Substantially Equivalent | Sterile Concepts, Inc. |
| K920978 | ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED | Feb 15, 1994 | Substantially Equivalent | ETHICON, Inc. |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | Jul 05, 1990 | Substantially Equivalent for Some Indications | American Cyanamid Co. |
| K895579 | POLYSORB SYNTHETIC ABSORBABLE SUTURE | Jul 05, 1990 | Substantially Equivalent for Some Indications | United States Surgical, A Division of Tyco Healthc |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.