Penrose Drain Models 6001 - 6007

Q: What is the product code of K960099?

The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.

FDA 510(k) K960099 · Sil-Med Corp.

Substantially Equivalent

510(k) numberK960099

Submission

Device name: Penrose Drain Models 6001 - 6007
Applicant: Sil-Med Corp.
Taunton, MA, US
Received: January 11, 1996
Decision date: March 11, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class: Class I (low risk)
Regulation: 21 CFR 878.4680
Specialty: General, Plastic Surgery

Other 510(k)s with product code GCY

510(k)	Device	Applicant	Decision
K972703	Redyrob-Closed Wound Drainage SystemGCY · Traditional	B.Braun Medical, Inc.	10/01/1997SE
K971036	Odontit Autogenous Bone Collection DeviceGCY · Traditional	Interpore Intl.	06/03/1997SE
K963839	Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional	Cordis Corp.	12/12/1996SE
K950754	Macro Suction Tube Model No 10061GCY · Traditional	Dlp, Inc.	04/25/1995SE
K936223	Pressure Irrigating SystemGCY · Traditional	Level 1 Technologies, Inc.	05/12/1994SE
K930615	Autovac Closed Wound Suction SystemGCY · Traditional	Boehringer Laboratories	02/22/1994SE
K933319	Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional	Birtcher Medical Systems, Inc.	10/27/1993SE
K933306	Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional	Inman Medical Corp.	10/05/1993SE
K933305	Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional	Inman Medical Corp.	10/05/1993SE
K933170	Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional	Inman Medical Corp.	09/16/1993SE

More from Inman Medical Corp.

510(k)	Device	Decision
K972521	Navigator (Stylet) 2006GAH · Traditional	10/01/1997SE
K961392	Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IIFJS · Traditional	07/18/1997SE
K961194	Antimicrobial Mediastinal Silicone DrainGBW · Traditional	08/08/1996SE
K961295	Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional	06/26/1996SE
K955463	Grip-A-BootsLXZ · Traditional	01/23/1996SE
K942709	Mediastinal Silicone DrainsGBW · Traditional	01/04/1996SN
K926496	Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional	05/24/1995SE
K926495	Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional	02/02/1994SE
K926408	Sil-Slip Flat Suction DrainGBX · Traditional	02/02/1994SE
K921424	Sil-Med Flat Suction DrainGBX · Traditional	09/28/1992SE

Questions and answers

When was Penrose Drain Models 6001 - 6007 cleared by the FDA?

Penrose Drain Models 6001 - 6007 (K960099) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 60 days after the submission was received.

What is the product code of K960099?

The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.