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FDA 510(k)

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

K-Number: K030684 · 2003-06-03

ApplicantAcmi Corporation
Decision Date2003-06-03
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2003-06-03 under 510(k) number K030684. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH?

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH is a medical device that received FDA 510(k) clearance on 2003-06-03. The listed applicant is Acmi Corporation. The 510(k) number is K030684.

When did SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH receive FDA 510(k) clearance?

SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH received FDA 510(k) clearance on 2003-06-03, under 510(k) number K030684.

Who is the listed applicant for SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH?

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

What is the FDA product code for SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH?

The FDA product code for SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH is OCU.

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Other records listing Acmi Corporation as applicant

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K061975PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PKK060752ACMI DUR-HL LASER SYSTEMSK060269ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEMK051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224K052044ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6ALK043581DUAL LUMEN CATHETER

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Related Devices (Code: OCU)

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.

K202838Andorate Universal Endoscope Tip GuardGa Health Company LimitedK191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileSTERIS CorporationK191011Scope ProTechMeditech Endoscopy, Ltd.K951104ENDOBOOTUnited States Endoscopy Group, Inc.K940780SCOPEJOCKEYFibertech Instruments, 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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