FDA 510(k)

SER-TEX

K-Number: K800834 · 1980-06-30

Decision Date1980-06-30

Product CodeKOH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SER-TEX is the device name listed in this FDA 510(k) record. The listed applicant is V.S.S.I., Inc.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K800834. The device is classified under product code KOH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SER-TEX?

SER-TEX is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is V.S.S.I., Inc.. The 510(k) number is K800834.

When did SER-TEX receive FDA 510(k) clearance?

SER-TEX received FDA 510(k) clearance on 1980-06-30, under 510(k) number K800834.

Who is the listed applicant for SER-TEX?

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

What is the FDA product code for SER-TEX?

The FDA product code for SER-TEX is KOH.

Related Devices (Code: KOH)

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.

K000212KSEA CHARDONNES MORCELLATION KNIFEKARL STORZ Endoscopy-America, Inc.K921730C-SECTION PACKMedikmark, Inc.K921732MINOR LAP SETMedikmark, Inc.K892693VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTZinnanti Surgical Instruments, Inc.K891351NEWPORT LATERAL VAGINAL RETRACTORSimpson/Basye, Inc.K891035NEEDLE EXTENSIONSZinnanti Surgical Instruments, 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.