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FDA 510(k)

POST OPERATIVE SPONGE

K-Number: K912693 · 1991-10-04

ApplicantUlti-Med Intl., Inc.
Decision Date1991-10-04
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POST OPERATIVE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K912693. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POST OPERATIVE SPONGE?

POST OPERATIVE SPONGE is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K912693.

When did POST OPERATIVE SPONGE receive FDA 510(k) clearance?

POST OPERATIVE SPONGE received FDA 510(k) clearance on 1991-10-04, under 510(k) number K912693.

Who is the listed applicant for POST OPERATIVE SPONGE?

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

What is the FDA product code for POST OPERATIVE SPONGE?

The FDA product code for POST OPERATIVE SPONGE is NAB.

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Other records listing Ulti-Med Intl., Inc. as applicant

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K103011ULTICARE SAFETY INSULIN SYRINGEK923175SURGICAL INSTRUMENT KIT, DISPOSABLEK923176SURGICAL INSTRUMENT KIT, DISPOSABLEK920989SURGICAL INSTRUMENT KIT, DISPOSABLEK922828ULCER WOUND TRAYK914244STERILE CUSTOM SURGICAL KITS

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Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle 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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