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FDA 510(k)

PROGEL(TM), MODELS 8630 AND 8635

K-Number: K882887 · 1988-09-29

ApplicantMedical Devices, Inc.
Decision Date1988-09-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROGEL(TM), MODELS 8630 AND 8635 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K882887. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGEL(TM), MODELS 8630 AND 8635?

PROGEL(TM), MODELS 8630 AND 8635 is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is Medical Devices, Inc.. The 510(k) number is K882887.

When did PROGEL(TM), MODELS 8630 AND 8635 receive FDA 510(k) clearance?

PROGEL(TM), MODELS 8630 AND 8635 received FDA 510(k) clearance on 1988-09-29, under 510(k) number K882887.

Who is the listed applicant for PROGEL(TM), MODELS 8630 AND 8635?

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

What is the FDA product code for PROGEL(TM), MODELS 8630 AND 8635?

The FDA product code for PROGEL(TM), MODELS 8630 AND 8635 is GXY.

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Other records listing Medical Devices, Inc. as applicant

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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