Endoscopic Hemostatic Ligating Loop
FDA 510(k) K902731 · United States Surgical, A Division of Tyco Healthc
510(k) numberK902731
Submission
- Device name
- Endoscopic Hemostatic Ligating Loop
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- June 21, 1990
- Decision date
- September 7, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAL – Suture, Absorbable, Natural
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4830
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Endoscopic Hemostatic Ligating Loop cleared by the FDA?
Endoscopic Hemostatic Ligating Loop (K902731) received a 510(k) decision of Substantially Equivalent for Some Indications on September 7, 1990, 78 days after the submission was received.
What is the product code of K902731?
The FDA product code is GAL – Suture, Absorbable, Natural, a Class II (moderate risk) device regulated under 21 CFR 878.4830.