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FDA 510(k)

LAPRO-LOADER(TM)

K-Number: K932689 · 1994-04-11

ApplicantSurgimark, Inc.
Decision Date1994-04-11
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPRO-LOADER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Surgimark, Inc.. It received FDA 510(k) clearance on 1994-04-11 under 510(k) number K932689. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPRO-LOADER(TM)?

LAPRO-LOADER(TM) is a medical device that received FDA 510(k) clearance on 1994-04-11. The listed applicant is Surgimark, Inc.. The 510(k) number is K932689.

When did LAPRO-LOADER(TM) receive FDA 510(k) clearance?

LAPRO-LOADER(TM) received FDA 510(k) clearance on 1994-04-11, under 510(k) number K932689.

Who is the listed applicant for LAPRO-LOADER(TM)?

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

What is the FDA product code for LAPRO-LOADER(TM)?

The FDA product code for LAPRO-LOADER(TM) is HET.

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Other records listing Surgimark, 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.

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Official Source

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