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FDA 510(k)

SANDHILL AMS

K-Number: K863312 · 1986-12-03

ApplicantSandhill
Decision Date1986-12-03
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SANDHILL AMS is the device name listed in this FDA 510(k) record. The listed applicant is Sandhill. It received FDA 510(k) clearance on 1986-12-03 under 510(k) number K863312. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDHILL AMS?

SANDHILL AMS is a medical device that received FDA 510(k) clearance on 1986-12-03. The listed applicant is Sandhill. The 510(k) number is K863312.

When did SANDHILL AMS receive FDA 510(k) clearance?

SANDHILL AMS received FDA 510(k) clearance on 1986-12-03, under 510(k) number K863312.

Who is the listed applicant for SANDHILL AMS?

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

What is the FDA product code for SANDHILL AMS?

The FDA product code for SANDHILL AMS is FAP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sandhill 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.

K854933SANDHILL ELECTRONIC CALIPERK821588SANDHILL DMS

Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.

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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