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FDA 510(k)

STERILE SUTURE REMOVAL SET

K-Number: K832047 · 1983-09-12

ApplicantOrmed Mfg., Inc.
Decision Date1983-09-12
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SUTURE REMOVAL SET is the device name listed in this FDA 510(k) record. The listed applicant is Ormed Mfg., Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832047. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE SUTURE REMOVAL SET?

STERILE SUTURE REMOVAL SET is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Ormed Mfg., Inc.. The 510(k) number is K832047.

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

STERILE SUTURE REMOVAL SET received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832047.

Who is the listed applicant for STERILE SUTURE REMOVAL SET?

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

What is the FDA product code for STERILE SUTURE REMOVAL SET?

The FDA product code for STERILE SUTURE REMOVAL SET is KDD.

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Other records listing Ormed Mfg., Inc. as applicant

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Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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