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Seal, Cervical, Mechanical, Unpowered

Page Type
Product Code
Definition
Reduce fluid leakage from the cervix during hysteroscopic procedures.
Physical State
These devices attach to the hysteroscope or sheath and contacts the cervix and forms a seal. They may be passive or may have simple mechanical action (e.g., springs) that facilitate contact between the distal tip and cervix to promote the seal.
Technical Method
These devices are simple mechanical devices that attach to a hysteroscope and form a physical seal between the hysteroscope and the cervix. The mechanical seal reduces leakage from the cervix during hysteroscopic procedures.
Target Area
Vagina, cervix, 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
Ineligible
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]

Seal, Cervical, Mechanical, Unpowered

Page Type
Product Code
Definition
Reduce fluid leakage from the cervix during hysteroscopic procedures.
Physical State
These devices attach to the hysteroscope or sheath and contacts the cervix and forms a seal. They may be passive or may have simple mechanical action (e.g., springs) that facilitate contact between the distal tip and cervix to promote the seal.
Technical Method
These devices are simple mechanical devices that attach to a hysteroscope and form a physical seal between the hysteroscope and the cervix. The mechanical seal reduces leakage from the cervix during hysteroscopic procedures.
Target Area
Vagina, cervix, 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
Ineligible
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]