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FDA 510(k)

SCOPE MASTER

K-Number: K811270 · 1981-09-08

ApplicantSynemed, Inc.
Decision Date1981-09-08
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SCOPE MASTER is the device name listed in this FDA 510(k) record. The listed applicant is Synemed, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K811270. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOPE MASTER?

SCOPE MASTER is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Synemed, Inc.. The 510(k) number is K811270.

When did SCOPE MASTER receive FDA 510(k) clearance?

SCOPE MASTER received FDA 510(k) clearance on 1981-09-08, under 510(k) number K811270.

Who is the listed applicant for SCOPE MASTER?

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

What is the FDA product code for SCOPE MASTER?

The FDA product code for SCOPE MASTER is HIH.

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Other records listing Synemed, 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.

K954037FIELD TRENDK852936THE FIELDMASTER MODEL 275K833274DERMATOLOGY HANDPIECE-OPHTH LASERK831085SYNEVAC VACUUM SOURCE UNITK828585OPTHALAS PHOTOCOAGULATORK822853MODEL 200 SQUID

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Related Devices (Code: HIH)

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.

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KGK261102UNIDRIVE Select SystemKarl Storz SE & CO. KGK254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., 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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