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FDA 510(k)

ADEPT ENDOSCOPIC POSITIONER

K-Number: K922625 · 1992-10-19

ApplicantAndronic Devices, Ltd.
Decision Date1992-10-19
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADEPT ENDOSCOPIC POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Andronic Devices, Ltd.. It received FDA 510(k) clearance on 1992-10-19 under 510(k) number K922625. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADEPT ENDOSCOPIC POSITIONER?

ADEPT ENDOSCOPIC POSITIONER is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Andronic Devices, Ltd.. The 510(k) number is K922625.

When did ADEPT ENDOSCOPIC POSITIONER receive FDA 510(k) clearance?

ADEPT ENDOSCOPIC POSITIONER received FDA 510(k) clearance on 1992-10-19, under 510(k) number K922625.

Who is the listed applicant for ADEPT ENDOSCOPIC POSITIONER?

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

What is the FDA product code for ADEPT ENDOSCOPIC POSITIONER?

The FDA product code for ADEPT ENDOSCOPIC POSITIONER is GAD.

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Other records listing Andronic Devices, Ltd. 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.

K940812INSIGHT ELECTRONIC ALIGNMENT INDICATORK934926INSITE MODEL 20 & MODEL 15 INSUFFLATORSK934928INSITE FILTER & TUBING SETK935381KAPS POSITIONING ARMK934124AUTOQUOT AUTOMATED ALIQUOTTING SYSTEMK936308ENDEX ENDOSCOPIC POSITIONING SYSTEM

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Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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