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FDA 510(k)

OBGRIP AND UNITIPS(TM)

K-Number: K930617 · 1993-08-11

ApplicantUnisurge, Inc.
Decision Date1993-08-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OBGRIP AND UNITIPS(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Unisurge, Inc.. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K930617. 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 OBGRIP AND UNITIPS(TM)?

OBGRIP AND UNITIPS(TM) is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Unisurge, Inc.. The 510(k) number is K930617.

When did OBGRIP AND UNITIPS(TM) receive FDA 510(k) clearance?

OBGRIP AND UNITIPS(TM) received FDA 510(k) clearance on 1993-08-11, under 510(k) number K930617.

Who is the listed applicant for OBGRIP AND UNITIPS(TM)?

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

What is the FDA product code for OBGRIP AND UNITIPS(TM)?

The FDA product code for OBGRIP AND UNITIPS(TM) is GCJ.

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Other records listing Unisurge, 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.

K943502UNIGRIPK933720INSTRUMENT ACTUATING DEVICE (IAD)K930605APPLIER, SURGICAL, CLIPK932604UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPICK925917UNICHANNEL(TM SURGICAL GRASPERK930809UNITIPS

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Related Devices (Code: GCJ)

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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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