← Product Code [GCY](/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY) · K960099 # PENROSE DRAIN MODELS 6001 - 6007 (K960099) _Sil-Med Corp. · GCY · Mar 11, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K960099 ## Device Facts - **Applicant:** Sil-Med Corp. - **Product Code:** [GCY](/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY.md) - **Decision Date:** Mar 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4680 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **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). ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K960099](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K960099) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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