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FDA 510(k)

SURGI-WIPE

K-Number: K942642 · 1994-07-15

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date1994-07-15
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGI-WIPE is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1994-07-15 under 510(k) number K942642. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-WIPE?

SURGI-WIPE is a medical device that received FDA 510(k) clearance on 1994-07-15. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K942642.

When did SURGI-WIPE receive FDA 510(k) clearance?

SURGI-WIPE received FDA 510(k) clearance on 1994-07-15, under 510(k) number K942642.

Who is the listed applicant for SURGI-WIPE?

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

What is the FDA product code for SURGI-WIPE?

The FDA product code for SURGI-WIPE is HOZ.

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Other records listing Surgin Surgical Instrumentation, 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.

K082110DUAL SYRINGE HOLDERK033236PRIZM KERATOME BLADE, MODEL MK8512M2K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDK011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBK994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508K980849SURGIN KIT

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Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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