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FDA 510(k)

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC

K-Number: K852331 · 1986-08-01

ApplicantScholten Surgical Instruments, Inc.
Decision Date1986-08-01
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC is the device name listed in this FDA 510(k) record. The listed applicant is Scholten Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K852331. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC?

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Scholten Surgical Instruments, Inc.. The 510(k) number is K852331.

When did SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC receive FDA 510(k) clearance?

SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC received FDA 510(k) clearance on 1986-08-01, under 510(k) number K852331.

Who is the listed applicant for SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC?

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

What is the FDA product code for SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC?

The FDA product code for SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC is IZI.

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Other records listing Scholten Surgical Instruments, 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.

K072051NOVATOME, MODEL: SU101-50K900405SCHOLTEN FRAMEK852119TEMPORARY PACEMAKER GROUND WIREK852332TABLE ACCESSORIES, OPERATING ROOMK852120FORCEPS, BIOPSY(NON RIGID)K852330RETRACTOR, SURGICAL

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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