← Product Code [GAN](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN) · K951231

# ORTHOPEDIC PACKS (K951231)

_Sterile Concepts, Inc. · GAN · Dec 1, 1995 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K951231

## Device Facts

- **Applicant:** Sterile Concepts, Inc.
- **Product Code:** [GAN](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN.md)
- **Decision Date:** Dec 1, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4830
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K951231](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAN/K951231)

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