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FDA 510(k)

POCKET COUNT OR SAFETCOUNT

K-Number: K972302 · 1997-07-25

ApplicantSage Products, Inc.
Decision Date1997-07-25
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POCKET COUNT OR SAFETCOUNT is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K972302. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POCKET COUNT OR SAFETCOUNT?

POCKET COUNT OR SAFETCOUNT is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Sage Products, Inc.. The 510(k) number is K972302.

When did POCKET COUNT OR SAFETCOUNT receive FDA 510(k) clearance?

POCKET COUNT OR SAFETCOUNT received FDA 510(k) clearance on 1997-07-25, under 510(k) number K972302.

Who is the listed applicant for POCKET COUNT OR SAFETCOUNT?

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

What is the FDA product code for POCKET COUNT OR SAFETCOUNT?

The FDA product code for POCKET COUNT OR SAFETCOUNT is LWH.

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Other records listing Sage Products, 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK972279SHARPS SHUTTLEK970135NITRILE GLOVESK964168PROCEDURE SPECIFIC KITS

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Related Devices (Code: LWH)

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.

K121274PIXEL APPGauss Surgical, Inc.,K120473PIXEL APPGauss Surgical, Inc.,K100551ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.K093557SMARTWAND-DTXClearcount Medical SolutionsK073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, 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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