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FDA 510(k)

LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT

K-Number: K943989 · 1994-09-12

ApplicantGabris Surgical Corp.
Decision Date1994-09-12
Product CodeHFO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gabris Surgical Corp.. It received FDA 510(k) clearance on 1994-09-12 under 510(k) number K943989. The device is classified under product code HFO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT?

LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT is a medical device that received FDA 510(k) clearance on 1994-09-12. The listed applicant is Gabris Surgical Corp.. The 510(k) number is K943989.

When did LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT receive FDA 510(k) clearance?

LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT received FDA 510(k) clearance on 1994-09-12, under 510(k) number K943989.

Who is the listed applicant for LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT?

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

What is the FDA product code for LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT?

The FDA product code for LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT is HFO.

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Other records listing Gabris Surgical Corp. 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.

K954774SHIELDED TROCAR (OBTURATOR)K953548LAPAROSCOPIC SURGICAL INSTRUMENTK944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITK944104GABRIS LAPAROSCOPIC SURGICAL KITSK944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTK930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

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Related Devices (Code: HFO)

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.

K973850ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007Alexander Mfg. Co.K791633UC-2000 UTERINE CATHERIZATION SYSTEMLife Support, Inc.K780487FETAL MONITORING SYSTEMSonicaid, Inc.

Official Source

View on FDA Database →

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

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