Suretip Syringe Tip Cover

FDA 510(k) K931772 · Western M/D, Inc.

Substantially Equivalent

510(k) numberK931772

Submission

Device name
Suretip Syringe Tip Cover
Applicant
Western M/D, Inc.
Burlingame, CA, US
Received
April 9, 1993
Decision date
March 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ECB – Unit, Syringe, Air And/Or Water
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code ECB

510(k)DeviceApplicantDecision
K942519Uni-Syringe, Uni-Tip and Access Syringe TipsECB · Traditional Bull Frog Mfg. Co.08/23/1994SE
K931137Dental Syringe TipECB · Traditional A-Dec, Inc.11/29/1993SE
K923876Riskontrol Single UseECB · Traditional Riskontrol04/05/1993SE
K923285Pro-Tip Disposable 3/1 Syringe NozzleECB · Traditional Smith & Nephew, Inc.09/15/1992SE
K920499Sani-TipECB · Traditional Dw Industries, Inc.05/03/1992SE
K911756Posterior Nasal Epistaxis InstrumentsECB · Traditional Richard Wolf Medical Instruments Corp.10/24/1991SE
K890290Brace (Orafix Special)ECB · Traditional Norcliff Thayer, Inc.03/29/1989SE
K863024Seringa Triplice S.L.ECB · Traditional Sds Dental, Inc.09/25/1986SE
K854699Tubing SyringECB · Traditional Almore Intl., Inc.01/06/1986SE
K801686Spaceline Three Way SyringeECB · Traditional Pacific Dental Corp.08/04/1980SE

More from Pacific Dental Corp.

510(k)DeviceDecision
K911214Nutip (TM) Syringe ShieldEKJ · Traditional 07/17/1991SE

Questions and answers

When was Suretip Syringe Tip Cover cleared by the FDA?

Suretip Syringe Tip Cover (K931772) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 332 days after the submission was received.

What is the product code of K931772?

The FDA product code is ECB – Unit, Syringe, Air And/Or Water, a Class I (low risk) device regulated under 21 CFR 872.4565.