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FDA 510(k)

WHISK-R

K-Number: K812694 · 1981-10-26

ApplicantMedi-Spec
Decision Date1981-10-26
Product CodeGEE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WHISK-R is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Spec. It received FDA 510(k) clearance on 1981-10-26 under 510(k) number K812694. The device is classified under product code GEE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHISK-R?

WHISK-R is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Medi-Spec. The 510(k) number is K812694.

When did WHISK-R receive FDA 510(k) clearance?

WHISK-R received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812694.

Who is the listed applicant for WHISK-R?

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

What is the FDA product code for WHISK-R?

The FDA product code for WHISK-R is GEE.

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Other records listing Medi-Spec 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.

K833068LAMINARIA JAPONICA CERVICAL DILATORK812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)K801554STERILE CAST PADDINGK800404MEDSPEC OPERATIVE OPTHALMIC KITK800490STERILE DRESSING PACKK790952CLAMP COVERS

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Related Devices (Code: GEE)

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.

K854003STERILE SOFT TISSUE BIOPSY NEEDLECo-Medical, Inc.K841008BIOPSY PUNCH, VARIOUSPremier Dental Products Co.K822490DEFLECTING CYTOLOGY BRUSHVan-Tec, Inc.K820259STERILE CYTOLOGY BRUSHESAmerican Endoscopy, Inc.K801304CAMLOC SYRINGE BIOPSY KITJohannah Medical Services, Inc.K792316TROTEX II SCREW NEEDLE BIOPSY INSTR. SETUrsus Konsult AB

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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