Deep Suture

FDA 510(k) K942818 · Automated Medical Products Corp.

Substantially Equivalent

510(k) numberK942818

Submission

Device name
Deep Suture
Applicant
Automated Medical Products Corp.
New York, NY, US
Received
June 15, 1994
Decision date
August 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MDM – Instrument, Manual, Surgical, General Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K010184Chess Hand Surgery SystemMDM · Traditional Canica Design, Inc.06/22/2001SE
K990062SaphliftMDM · Traditional Genzyme Surgical Product (Genzyme Biosurgery)03/30/1999SE
K981579Endopouch Pro Specimen Retrieval BagMDM · Traditional ETHICON, Inc.07/09/1998SE
K943968TunnelerMDM · Traditional Denver Biomedicals, Inc.03/01/1995SE

More from Denver Biomedicals, Inc.

510(k)DeviceDecision
K942910DeepvisonGCJ · Traditional 07/21/1995SE
K942002RetractorGAD · Traditional 05/17/1994SE
K940199DissectorGCJ · Traditional 03/30/1994SE
K832827Corpuls 300LDD · Traditional 11/03/1983SE
K792145Automatic Retractor HoldersGAD · Traditional 12/05/1979SE

Questions and answers

When was Deep Suture cleared by the FDA?

Deep Suture (K942818) received a 510(k) decision of Substantially Equivalent on August 25, 1994, 71 days after the submission was received.

What is the product code of K942818?

The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.