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FDA 510(k)

FLEXIBLE SILICONE GELIHORN

K-Number: K920187 · 1992-10-23

ApplicantBioteque America, Inc.
Decision Date1992-10-23
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE SILICONE GELIHORN is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque America, Inc.. It received FDA 510(k) clearance on 1992-10-23 under 510(k) number K920187. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE SILICONE GELIHORN?

FLEXIBLE SILICONE GELIHORN is a medical device that received FDA 510(k) clearance on 1992-10-23. The listed applicant is Bioteque America, Inc.. The 510(k) number is K920187.

When did FLEXIBLE SILICONE GELIHORN receive FDA 510(k) clearance?

FLEXIBLE SILICONE GELIHORN received FDA 510(k) clearance on 1992-10-23, under 510(k) number K920187.

Who is the listed applicant for FLEXIBLE SILICONE GELIHORN?

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

What is the FDA product code for FLEXIBLE SILICONE GELIHORN?

The FDA product code for FLEXIBLE SILICONE GELIHORN is HHW.

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Other records listing Bioteque America, 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.

K041094HSG CATHETER SETK020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5K013289BIOTEQUE VAGINAL PESSARIESK003380BIOTEQUE VAGINAL DILATORK920633PESSARY FLEXIBLE SILICONE NICHOLSK920747PESSARY FLEXIBLE SILICONE DONUT RING

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Related Devices (Code: HHW)

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.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, 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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