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Drill, Battery Powered, Subungual Hematoma

Page Type
Product Code
Definition
Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe).
Physical State
The device is comprised of a hand-held cutter, sensing electrodes and a battery pack.
Technical Method
The device uses a 6V cutter motor to rotate the cutter and a 6V vertical drive motor to move the cutter towards and away from the nail. The motors are powered by a 9V battery.
Target Area
Finger nails and toe nails.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4820 Surgical instrument motors and accessories/attachments

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a) 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000]

Drill, Battery Powered, Subungual Hematoma

Page Type
Product Code
Definition
Intended to cut a hole in finger and toe nails to release fluid accumulated in the underlying nail bed. Indicated to relieve pressure from subungual hematomas (including black toe).
Physical State
The device is comprised of a hand-held cutter, sensing electrodes and a battery pack.
Technical Method
The device uses a 6V cutter motor to rotate the cutter and a 6V vertical drive motor to move the cutter towards and away from the nail. The motors are powered by a 9V battery.
Target Area
Finger nails and toe nails.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4820 Surgical instrument motors and accessories/attachments

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a) 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.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2318, 2000]