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FDA 510(k)

STRAITH DRAIN INSERTER

K-Number: K840835 · 1984-04-23

ApplicantSurgical Technology Laboratories, Inc.
Decision Date1984-04-23
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRAITH DRAIN INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K840835. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAITH DRAIN INSERTER?

STRAITH DRAIN INSERTER is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K840835.

When did STRAITH DRAIN INSERTER receive FDA 510(k) clearance?

STRAITH DRAIN INSERTER received FDA 510(k) clearance on 1984-04-23, under 510(k) number K840835.

Who is the listed applicant for STRAITH DRAIN INSERTER?

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

What is the FDA product code for STRAITH DRAIN INSERTER?

The FDA product code for STRAITH DRAIN INSERTER is FZX.

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Other records listing Surgical Technology Laboratories, Inc. 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.

K170582Saf-T-Vac Smoke and Fluid EvacuatorK021889SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)K983754STANDARD CHINK983755NASAL DORSAL SERIESK983756SURGIFORM ANATOMICAL MALARK964443SURGIFORM ANATOMICAL MALAR

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Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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