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FDA 510(k)

LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE

K-Number: K951990 · 1995-09-08

ApplicantSchoelly Technologies, Inc.
Decision Date1995-09-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Technologies, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K951990. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE?

LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Schoelly Technologies, Inc.. The 510(k) number is K951990.

When did LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE receive FDA 510(k) clearance?

LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE received FDA 510(k) clearance on 1995-09-08, under 510(k) number K951990.

Who is the listed applicant for LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE?

The FDA 510(k) record lists Schoelly Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE?

The FDA product code for LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE is GCJ.

Related Clinical Trials

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Other records listing Schoelly Technologies, Inc. as applicant

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.

K943426ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE

Related Devices (Code: GCJ)

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.

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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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