Clearance Summary
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) received FDA 510(k) clearance under submission number K893869, sponsored by Adept-Med Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-08-03.
- Submission: K893869
- Applicant / Sponsor: Adept-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-08-03
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.