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FDA 510(k)

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

K-Number: K011514 · 2001-08-13

ApplicantKencap , Ltd.
Decision Date2001-08-13
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Kencap , Ltd.. It received FDA 510(k) clearance on 2001-08-13 under 510(k) number K011514. 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 INSTRUMENTS FOR ONE TIME USE - DISPOSABLE?

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE is a medical device that received FDA 510(k) clearance on 2001-08-13. The listed applicant is Kencap , Ltd.. The 510(k) number is K011514.

When did INSTRUMENTS FOR ONE TIME USE - DISPOSABLE receive FDA 510(k) clearance?

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE received FDA 510(k) clearance on 2001-08-13, under 510(k) number K011514.

Who is the listed applicant for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE?

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

What is the FDA product code for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE?

The FDA product code for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE is KDD.

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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 PROCEDURESCovidienK971317NATIONAL 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.K923176SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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