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FDA 510(k)

SURGITEK MEDI-LOOPS

K-Number: K803156 · 1981-01-15

ApplicantMedical Engineering Corp.
Decision Date1981-01-15
Product CodeKDC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGITEK MEDI-LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1981-01-15 under 510(k) number K803156. The device is classified under product code KDC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK MEDI-LOOPS?

SURGITEK MEDI-LOOPS is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is Medical Engineering Corp.. The 510(k) number is K803156.

When did SURGITEK MEDI-LOOPS receive FDA 510(k) clearance?

SURGITEK MEDI-LOOPS received FDA 510(k) clearance on 1981-01-15, under 510(k) number K803156.

Who is the listed applicant for SURGITEK MEDI-LOOPS?

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

What is the FDA product code for SURGITEK MEDI-LOOPS?

The FDA product code for SURGITEK MEDI-LOOPS is KDC.

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Other records listing Medical Engineering 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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Related Devices (Code: KDC)

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.

K943229DISPOSABLE SURGICAL SCISSORS AND FORCEPSY.M.K. International Co., Ltd.K936226SURGIMED BREAST LOCALIZATION NEEDLE WIRE SETMeadox Medicals, Div. Boston Scientific Corp.K920153THERMUFF BAGTechstylesK920263MANUAL SURGICAL INSTRUMENTSPhoenix Instruments Div.K915064DISPOSABLE CAUTERY ABRASIVE PADAmerican Medical Mfg., Inc.K914960INSTRUMENT ORGANIZERO.R. Concepts, 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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