← Product Code [GFD](/submissions/SU/subpart-e%E2%80%94surgical-devices/GFD) · K962371 # DERMTOME BLADE (K962371) _Dsp Worldwide · GFD · Aug 29, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GFD/K962371 ## Device Facts - **Applicant:** Dsp Worldwide - **Product Code:** [GFD](/submissions/SU/subpart-e%E2%80%94surgical-devices/GFD.md) - **Decision Date:** Aug 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4820 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes. ## Device Story Stainless steel blade; accessory to Padgett dermatomes; secures to dermatome head via nut; oscillates in horizontal plane to harvest split-thickness skin grafts; single-use; disposable; sterile; gamma-sterilized; used by surgeons in clinical/surgical settings. ## Clinical Evidence Bench testing only. ## Technological Characteristics Stainless steel construction; oscillating blade mechanism; single-size; gamma sterilization; Tyvek/polypropylene packaging. ## Regulatory Identification Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. ## Predicate Devices - Padgett Dermatome Blades ## 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} AUG 29 1996 K962371 # 510(k) Summary ## DSP Worldwide Snowden-Pencer Dermatome Blade *(per 21 CFR 807.92)* 1. Date of Preparation June 18, 1996 2. Sponsor/Applicant DSP Worldwide Snowden-Pencer 5175 South Royal Atlanta Drive Tucker, GA 30084 DSP Worldwide 600 Airport Road Fall River, MA 02720-4740 3. Contact Name Timothy N. Thomas, Vice President, Regulatory Affairs and Quality Assurance DSP Worldwide Telephone: 508-677-6545 4. Device Name Trade/Proprietary Name: Dermatome blade Common/Usual Name: Padgett dermatome blade Classification Name: Accessory to Padgett Dermatome 5. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed: Padgett Dermatome Blades DSP Worldwide Snowden-Pencer - Dermatome Blade 510(k) 6/18/96 Page D-1 {1} 6. Device Description The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization. 7. Intended Use The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes. 8. Comparison of Technological Characteristics The DSP Worldwide Snowden-Pencer Dermatome Blade is equivalent to other currently marketed Padgett type dermatome blades in design, materials, operational characteristics, and sterility. Any difference between devices is minor and raises no new issues of safety and effectiveness. DSP Worldwide Snowden-Pencer - Dermatome Blade 510(k) 6/18/96 Page D-2 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GFD/K962371](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GFD/K962371) **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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