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FDA 510(k)

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD

K-Number: K882346 · 1988-06-30

ApplicantNordbye, Milchman, Barlage
Decision Date1988-06-30
Product CodeFYF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Nordbye, Milchman, Barlage. It received FDA 510(k) clearance on 1988-06-30 under 510(k) number K882346. The device is classified under product code FYF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD?

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD is a medical device that received FDA 510(k) clearance on 1988-06-30. The listed applicant is Nordbye, Milchman, Barlage. The 510(k) number is K882346.

When did INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD receive FDA 510(k) clearance?

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD received FDA 510(k) clearance on 1988-06-30, under 510(k) number K882346.

Who is the listed applicant for INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD?

The FDA 510(k) record lists Nordbye, Milchman, Barlage as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD?

The FDA product code for INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD is FYF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: FYF)

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.

K972227SHOE COVERAmerican Seal Co.K955833NIOMED SURGICAL CAPSAmerasia Corp.K954556SURGICAL CAPThai Disposable Products Co., Ltd.K954454NIOMED SURGICAL HOODAmerasia Corp.K954455NIOMED BOUFFANT CAPSAmerasia Corp.K953878BOUFFANT CAPAmerican Threshold Industries, 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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