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FDA 510(k)

ACU-SUTURE KIT

K-Number: K933137 · 1994-02-22

ApplicantAcuderm, Inc.
Decision Date1994-02-22
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACU-SUTURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Acuderm, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K933137. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-SUTURE KIT?

ACU-SUTURE KIT is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Acuderm, Inc.. The 510(k) number is K933137.

When did ACU-SUTURE KIT receive FDA 510(k) clearance?

ACU-SUTURE KIT received FDA 510(k) clearance on 1994-02-22, under 510(k) number K933137.

Who is the listed applicant for ACU-SUTURE KIT?

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

What is the FDA product code for ACU-SUTURE KIT?

The FDA product code for ACU-SUTURE KIT is LRO.

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Other records listing Acuderm, 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.

K933516ACU-E PUNCHK933265ACU-DISPO-CE(TM)K930043ACU-EVACK933866ACU-HEMOSTATIC RINGK915000ACU-GUARDK891334ACU-CURETTE

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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