3DSCOPE

FDA 510(k) K923160 · American Surgical Technologies Corp.

Substantially Equivalent

510(k) numberK923160

Submission

Device name
3DSCOPE
Applicant
American Surgical Technologies Corp.
Haverhiill, MA, US
Received
June 29, 1992
Decision date
December 10, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FWF – Camera, Television, Endoscopic, Without Audio
Device class
Class I (low risk)
Regulation
21 CFR 878.4160
Specialty
General, Plastic Surgery

Other 510(k)s with product code FWF

510(k)DeviceApplicantDecision
K053412Flexiscope, Models 50MH and 50 MHCFWF · Traditional Schoelly Imaging, Inc.02/23/2006SE
K990154Karl Storz Direct Coupled Interface (Dci 5) Camera SystemFWF · Traditional Karl Storz Imaging, Inc.06/01/1999SE
K982754EC-1000-7 Digital Endoscopy Video Camera, Models Ec 1000-7P (Pal) & Ec 1000-7N (NTSC)FWF · Traditional A.Stein - Regulatory Affairs Consulting01/08/1999SE
K982965Endocam Camera Systems 5502/5507 with CR Camera Heads and AccessoriesFWF · Traditional Richard Wolf Medical Instruments Corp.11/23/1998SE
K982397Ves 3001-M Complete Video Endoscopic SystemFWF · Traditional Angiolaz, Inc.09/10/1998SE
K982409Ves 1501-MFWF · Traditional Angiolaz, Inc.08/21/1998SE
K981819Angiolaz VES-1CAMFWF · Traditional Angiolaz, Inc.08/04/1998SE
K944707Isolated Camera HeadFWF · Traditional Envision Medical Corp.10/07/1994SE
K930297Fujinon Video Laparoscope, ModifiedFWF · Traditional Fujinon, Inc.03/29/1994SE
K934682Surgical Video Camera and AccessoriesFWF · Traditional Medical Dynamics, Inc.02/15/1994SE

Questions and answers

When was 3DSCOPE cleared by the FDA?

3DSCOPE (K923160) received a 510(k) decision of Substantially Equivalent on December 10, 1992, 164 days after the submission was received.

What is the product code of K923160?

The FDA product code is FWF – Camera, Television, Endoscopic, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.