Identi-Clamps

FDA 510(k) K780721 · Berkeley Bio-Medical, Inc.

Substantially Equivalent

510(k) numberK780721

Submission

Device name
Identi-Clamps
Applicant
Berkeley Bio-Medical, Inc.
Mchenry, IL, US
Received
May 1, 1978
Decision date
October 17, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GDJ – Clamp, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K914913Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional Ideal Medical, Inc.12/31/1991SE
K900956GS-7100 Cholangiogram Clamp, 5MMGDJ · Traditional Solos Endoscopy, Inc.04/18/1990SE
K901107Modified Auto Suture Purstring Disp. AutomaticGDJ · Traditional United States Surgical, A Division of Tyco Healthc04/09/1990SE
K895726Vessel OccluderGDJ · Traditional Applied Medical Technologies10/24/1989SE
K895591Silicone Instrument ShodsGDJ · Traditional Key Surgical, Inc.10/20/1989SE
K882169Surgical Duct Clamp (Vine)GDJ · Traditional Henley Intl.06/17/1988SE

More from Henley Intl.

510(k)DeviceDecision
K780720Identi-LoopsGAD · Traditional 10/17/1978SE

Questions and answers

When was Identi-Clamps cleared by the FDA?

Identi-Clamps (K780721) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 169 days after the submission was received.

What is the product code of K780721?

The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.