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Hysteroscope Accessories

Page Type
Product Code
Definition
Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Physical State
Metal instruments
Technical Method
Part of system that advances through the working channel of the hysteroscope to perform it's function.
Target Area
Uterus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.1690
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.1690 Hysteroscope and accessories

§ 884.1690 Hysteroscope and accessories.

(a) Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

(b) Classification. (1) Class II (performance standards).

(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]

Hysteroscope Accessories

Page Type
Product Code
Definition
Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.
Physical State
Metal instruments
Technical Method
Part of system that advances through the working channel of the hysteroscope to perform it's function.
Target Area
Uterus
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.1690
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.1690 Hysteroscope and accessories

§ 884.1690 Hysteroscope and accessories.

(a) Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

(b) Classification. (1) Class II (performance standards).

(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001]