Who is the manufacturer of PENROSE DRAIN MODELS 6001 - 6007?

Sil-Med Corp. filed the 510(k) submission for PENROSE DRAIN MODELS 6001 - 6007 (K960099).

What is the FDA product code for PENROSE DRAIN MODELS 6001 - 6007?

GCY. It is classified under 21 CFR 878.4680 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PENROSE DRAIN MODELS 6001 - 6007?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PENROSE DRAIN MODELS 6001 - 6007?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PENROSE DRAIN MODELS 6001 - 6007

K960099 · Sil-Med Corp. · GCY · Mar 11, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960099
Device Name	PENROSE DRAIN MODELS 6001 - 6007
Applicant	Sil-Med Corp.
Product Code	GCY · General, Plastic Surgery
Decision Date	Mar 11, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4680
Device Class	Class 1
Attributes	Therapeutic

Intended Use

Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.

Device Story

Passive wound drain; silicone construction; flat design; internal diameter teeth to prevent collapse; radiopaque stripe for visualization. Used post-operatively in clinical settings to facilitate drainage of serosanguineous fluids from soft tissue sites. Operated by clinicians; device functions via gravity-assisted drainage. Sold sterile for single-patient use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Rabbit Pyrogen (non-pyrogenic), Hemolysis (non-hemolytic), Salmonella typhimurium reverse mutation assay (non-mutagenic), Kligman Maximization (Grade I), USP Class VI (satisfied), Elution test (non-cytotoxic), and 90-day USP muscle implantation study in rabbits (met requirements).

Technological Characteristics

Material: Silicone. Features: Flat geometry, internal diameter teeth, radiopaque stripe. Dimensions: 18" length. Sterilization: Sterile. Energy source: None (passive).

Indications for Use

Indicated for post-operative patients requiring passive drainage of serosanguineous fluids from soft tissue operative sites.

Regulatory Classification

Identification

A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

Predicate Devices

Davol Gravity Drain

Related Devices

K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR · Sil-Med Corp. · Jun 26, 1996
K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN · Allegiance Healthcare Corp. · Dec 4, 1997
K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR · Axiom Medical, Inc. · Mar 10, 1997
K993592 — AXIOM MULTIPURPOSE WOUND DRAIN · Axiom Medical, Inc. · May 17, 2000
K063245 — ELUTIA COATED CLOSED SURGICAL WOUND DRAIN · Bacterin International, Inc. · Nov 28, 2007

Submission Summary (Full Text)

{0} K960099 1 of 2 ![img-0.jpeg](img-0.jpeg) # SIL-MED ## Sil-Med Corporation 700 WARNER BLVD. TAUNTON, MA 02780 (508) 823-7701 FAX: (508) 823-1438 MAR 11 1996 ## 510 (k) Summary Company: Sil-Med Corporation 700 Warner Boulevard Taunton, MA 02780 Telephone: (508) 823-7701 Fax: (508) 823-1438 Contact Person: Karen K. Sylvia QA/QC Manager Trade Name: Penrose Drain Common Name: Flat Silicone Drain Classification Name: Apparative, Single Patient Use, Portable, Non-Powered (878.4680) Description: Passive Wound Drain Predicate Device: Davol Gravity Drain Intended Use: Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site. ### Biocompatibility Testing: | Test | Results | | --- | --- | | Rabbit Pyrogen Test | non-pyrogenic | | Hemolysis-Rabbit Blood | non-hemolytic at 2.02% Hemolysis | | Salmonella typhimurium REVERSE Mutation ASSAY | non-mutagenic | | Kligman Maximization Study (Cottonseed Oil Extract) | Grade I - weak allergenic potential (not considered significant) | | Kligman Maximization Study (Sodium Chloride Extract) | Grade I - weak allergenic potential (not considered significant) | | USP CLASS VI | Satisfied the requirements of USP XXII Biological Test for Plastics, Class VI-121°C | | ELUTION TEST | non-cytotoxic | | USP MUSCLE IMPLANTATION STUDY IN RABBITS WITH HISTOPATHOLOGY (90 Days) | met USP requirements | {1} K960099 2012 Sil-Med Corporation 510 (k) Summary Penrose Drain page 2 Sil-Med Corporation's Penrose Drain is dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Davol Gravity Drains are sold sterile and non sterile. Sil-Med Penrose Drains are sold sterile only. The intended use of both drains is equivalent. Date: 1/10/96