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FDA 510(k)

ST-610 NEEDLESCOPE STERILIZATION TRAY

K-Number: K823297 · 1983-05-06

ApplicantMedigroup
Decision Date1983-05-06
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ST-610 NEEDLESCOPE STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medigroup. It received FDA 510(k) clearance on 1983-05-06 under 510(k) number K823297. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST-610 NEEDLESCOPE STERILIZATION TRAY?

ST-610 NEEDLESCOPE STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 1983-05-06. The listed applicant is Medigroup. The 510(k) number is K823297.

When did ST-610 NEEDLESCOPE STERILIZATION TRAY receive FDA 510(k) clearance?

ST-610 NEEDLESCOPE STERILIZATION TRAY received FDA 510(k) clearance on 1983-05-06, under 510(k) number K823297.

Who is the listed applicant for ST-610 NEEDLESCOPE STERILIZATION TRAY?

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

What is the FDA product code for ST-610 NEEDLESCOPE STERILIZATION TRAY?

The FDA product code for ST-610 NEEDLESCOPE STERILIZATION TRAY is HET.

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Other records listing Medigroup 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.

K823294MEDIGROUP LS-110 LIGHT SOURCEK823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&K823293MEDIGROUP LG-102 LIGHT GUIDEK823331PC-204 TUNNELORK823390PC 201A LOCKING SLEEVEK823303QUILL CATHETER GUIDE

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Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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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