Cleared Traditional

SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT

K870518 · Surgitek · General Hospital
Apr 1987
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K870518 is an FDA 510(k) clearance for the SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on April 29, 1987, 83 days after receiving the submission on February 5, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K870518 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1987
Decision Date April 29, 1987
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

Similar Devices — FMF Syringe, Piston

All 747
Profoject? Insulin Syringes; Profoject? Safelock Disposable Insulin Syringe
K253068 · CMT Health PTE., Ltd. · Feb 2026
Instylla Delivery Kit
K253769 · Instylla, Inc. · Dec 2025
DuoprossTM Smart Cap (Type I)
K252518 · Duopross Meditech Corporate · Dec 2025
EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch? Safety Needle; EXEL Disposable Hypodermic Needle
K251089 · Exelint International, Co. · Dec 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · Promisemed Hangzhou Meditech Co., Ltd. · Dec 2025
Merit Syringe
K250853 · Merit Medical Systems, Inc. · Nov 2025