← Product Code [GAH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAH) · K970306 # MARKMAN TEMPLATE SYSTEM (K970306) _Barry Markman, M.D. · GAH · Nov 20, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAH/K970306 ## Device Facts - **Applicant:** Barry Markman, M.D. - **Product Code:** [GAH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GAH.md) - **Decision Date:** Nov 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4800 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner. ## Device Story Markman Template System is a surgical instrument for hair restoration. Device creates slits in scalp recipient sites and inserts preloaded hair grafts via cartridges. Used in clinical settings by physicians to improve efficiency of graft placement. System facilitates manual insertion process; benefits include standardized graft placement and reduced procedure time. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical surgical instrument for scalp incision and graft insertion. Includes cartridge-based delivery system. No electronic components, software, or energy sources. ## Regulatory Identification A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Barry Markman, M.D. 3085 E. Flamingo, Suite A Las Vegas, Nevada 89121 NOV 20 1997 Re: K970306 Trade Name: Markman Template System Regulatory Class: I Product Code: GAH Dated: September 5, 1997 Received: September 9, 1997 Dear Dr. Markman: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} Page 2 - Barry Markman, M.D. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Enclosure {2} 510(k) Number (if known): K970306 Device Name: MARKMAN TEMPLATE SYSTEM Indications for use: The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-1.jpeg](img-1.jpeg) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAH/K970306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GAH/K970306) **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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