Company · US

Aspen Surgical Products, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2003. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)

33recalls (0 in 12 months)

3recalls that name a 510(k)

Product codes

Code	Device	Records
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	21
HMR	Marker, Ocular	6
CCX	Support, Patient Position	3
FPX	Strip, Adhesive, Closure, Skin	1
FTA	Light, Surgical, Accessories	1
GCJ	Laparoscope, General & Plastic Surgery	1
GEI	Electrosurgical, Cutting & Coagulation & Accessories	1
KOG		1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Mar 7, 2003	K030339	CAUTERY TIP CLEANER, MODEL-TC-100 Aspen Surgical Products, Inc.	GEI
Feb 14, 2002	K020304	DISPOSABLE LIGHT HANDLE AND ADAPTOR Aspen Surgical Products, Inc.	FTA

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jul 23, 2021	Aspen Surgical Products, Inc. Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400 Terminated	CCX	None listed
Jul 23, 2021	Aspen Surgical Products, Inc. Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100 Terminated	CCX	None listed
Jul 23, 2021	Aspen Surgical Products, Inc. Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300 Terminated	CCX	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforate Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Apr 7, 2014	Aspen Surgical Products, Inc. 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage Terminated	GCY	None listed
Aug 20, 2013	Aspen Surgical Products, Inc. Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product N Terminated	FPX	K874813
Feb 16, 2011	Aspen Surgical Products, Inc. Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery. Terminated	HMR	None listed
Feb 16, 2011	Aspen Surgical Products, Inc. Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery. Terminated	HMR	None listed
Feb 16, 2011	Aspen Surgical Products, Inc. CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery. Terminated	HMR	None listed
Feb 16, 2011	Aspen Surgical Products, Inc. Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery. Terminated	HMR	None listed
Feb 16, 2011	Aspen Surgical Products, Inc. Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery. Terminated	HMR	None listed
Feb 16, 2011	Aspen Surgical Products, Inc. Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery. Terminated	HMR	None listed
May 22, 2009	Aspen Surgical Products, Inc. Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator, Sterion Inc., Ham L Terminated	GCY	None listed
May 22, 2009	Aspen Surgical Products, Inc. Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile, Sterion Inc., Ham Lake, MN; REF 332187. The device is a ste Terminated	GCY	None listed
Jun 16, 2005	Aspen Surgical Products, Inc. Dr. Fog Endoscopic fog prevention kit. Terminated	KOG	K932449
May 15, 2003	Aspen Surgical Products, Inc. Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge. Terminated	GCJ	K932449

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