FDA 510(k)

STYLETTE, SLICK, CAT. NO. 2000B

K-Number: K770374 · 1977-03-30

ApplicantMedical Products Div. P.O.L.A. Plasti

Decision Date1977-03-30

Product CodeBSR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STYLETTE, SLICK, CAT. NO. 2000B is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products Div. P.O.L.A. Plasti. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770374. The device is classified under product code BSR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STYLETTE, SLICK, CAT. NO. 2000B?

STYLETTE, SLICK, CAT. NO. 2000B is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Medical Products Div. P.O.L.A. Plasti. The 510(k) number is K770374.

When did STYLETTE, SLICK, CAT. NO. 2000B receive FDA 510(k) clearance?

STYLETTE, SLICK, CAT. NO. 2000B received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770374.

Who is the listed applicant for STYLETTE, SLICK, CAT. NO. 2000B?

The FDA 510(k) record lists Medical Products Div. P.O.L.A. Plasti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STYLETTE, SLICK, CAT. NO. 2000B?

The FDA product code for STYLETTE, SLICK, CAT. NO. 2000B is BSR.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: BSR)

K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook Incorporated K962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDLaerdal Medical Corp.K954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)Laerdal Medical Corp.K943104MOLLOY INTUBATING STYLETTEMolloy Corp.K955238RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLERusch Intl.K953677LIGHTED FLEXGUIDE (MODIFICATION)Scientific Sales 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.