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FDA 510(k)

3DSCOPE

K-Number: K923160 · 1992-12-10

ApplicantAmerican Surgical Technologies Corp.
Decision Date1992-12-10
Product CodeFWF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3DSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Technologies Corp.. It received FDA 510(k) clearance on 1992-12-10 under 510(k) number K923160. The device is classified under product code FWF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DSCOPE?

3DSCOPE is a medical device that received FDA 510(k) clearance on 1992-12-10. The listed applicant is American Surgical Technologies Corp.. The 510(k) number is K923160.

When did 3DSCOPE receive FDA 510(k) clearance?

3DSCOPE received FDA 510(k) clearance on 1992-12-10, under 510(k) number K923160.

Who is the listed applicant for 3DSCOPE?

The FDA 510(k) record lists American Surgical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DSCOPE?

The FDA product code for 3DSCOPE is FWF.

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Related Devices (Code: FWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053412FLEXISCOPE, MODELS 50MH AND 50 MHCSchoelly Imaging, Inc.K990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.K982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs ConsultingK982965ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIESRichard Wolf Medical Instruments Corp.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMAngiolaz, Inc.K982409VES 1501-MAngiolaz, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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