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FDA 510(k)

HYPO SUTURE

K-Number: K834138 · 1984-01-27

ApplicantMedical Design & Manufacturing Corp.
Decision Date1984-01-27
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPO SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K834138. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPO SUTURE?

HYPO SUTURE is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K834138.

When did HYPO SUTURE receive FDA 510(k) clearance?

HYPO SUTURE received FDA 510(k) clearance on 1984-01-27, under 510(k) number K834138.

Who is the listed applicant for HYPO SUTURE?

The FDA 510(k) record lists Medical Design & Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPO SUTURE?

The FDA product code for HYPO SUTURE is GAG.

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Other records listing Medical Design & Manufacturing Corp. as applicant

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Related Devices (Code: GAG)

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.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, 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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