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FDA 510(k)

SUTURE REMOVAL KIT

K-Number: K855131 · 1986-01-13

ApplicantDynarex Corp.
Decision Date1986-01-13
Product CodeJOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUTURE REMOVAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K855131. The device is classified under product code JOK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE REMOVAL KIT?

SUTURE REMOVAL KIT is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Dynarex Corp.. The 510(k) number is K855131.

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

SUTURE REMOVAL KIT received FDA 510(k) clearance on 1986-01-13, under 510(k) number K855131.

Who is the listed applicant for SUTURE REMOVAL KIT?

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

What is the FDA product code for SUTURE REMOVAL KIT?

The FDA product code for SUTURE REMOVAL KIT is JOK.

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Other records listing Dynarex 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.

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEK012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414K012957TOWEL DRAPE, MODELS 4409, 4410K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BK991695DYNAREX NON-WOVEN SPONGE

View all 19 devices →

Related Devices (Code: JOK)

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.

K843075UTILITY SCISSORS DISPOSABLE ITEMSGreene International Corp.K812555DISPOSABLE SUTURE REMOVAL SCISSORSMedcare ProductsK770595SUTURE REMOVAL SETAbco Dealers, Inc.K770481SHEAR, PLASTIC HANDLE UTILITY S-475-7Acme United Corp.K770163SUTURE CUTTERConcept, Inc.K761192DRESSING CHANGE KITSuperior Plastic Products Corp.

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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